Devices

New Device Inspection Protocol Analyzed

Three Hogan Lovells attorneys say FDA’s new medical device inspection protocol that aligns with the new Quality Management System Regulation will require device manufacturers to prepare for a significant operational and cultural transformation for undergoing, addressing, and responding to inspections and remote regulatory assessments. Writing in an online post, the attorneys say manufacturers will be expected to not only demonstrate procedural compliance with QMS regulations, but also confirm affirmatively with evidence the existence of a robust, self-correcting quality culture.

The post recommends that manufacturers evaluate whether their current systems (1) demonstrate closed-loop use of risk information, (2) reflect genuine management involvement, and (3) can withstand FDA review of internal audits, supplier oversight, and life-cycle data integration. “Early preparation will be critical to avoid inspection surprises under the new compliance program (CP),” they conclude.

The new CP 7382.850 marks a significant shift in FDA inspection methodology, the attorneys say. It establishes an expansive model for assessing product and process risks, all centered around risk to patients and users. The new program organizes inspection emphasis into six Quality Management System areas (change control; design and development; management oversight; measurement, analysis, and improvement; outsourcing and purchasing; and production and service provision) and four categories of Other Applicable FDA Requirements (medical device reporting, corrections and removals, tracking, and unique device identification).

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome